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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

WSJ: Panel Assessing Bayer Birth Control Pills Had Ties to Company

An advisory committee convened by the US Food and Drug Administration (FDA) to assess the safety of four Bayer AG birth control products had at least three members with ties to the company, according to The Wall Street Journal.

The panelists, whose ties with Bayer included serving as consultants, speakers or researchers, did not have their ties to the company disclosed to the public by FDA.

An FDA official, Jill Hartzler, told TheWall Street Journal that FDA is "prohibited from giving the public any information contained in a financial disclosure", but that the agency independently assesses the potential biases of a panelist.

Anyone testifying to the committee, however, is obligated to disclose any such ties for the public record.

Steven Nissen, a Cleveland Clinic cardiologist and longtime critic of FDA noted that the "lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process."

Bayer noted that it had no input regarding the composition of the panel, and reiterated its confidence in the safety of their product.

While the three panelists with potential conflicts of interest were allowed to vote, a fourth member of the committee, Public Citizen's Sidney Wolfe, was pulled from the committee for "intellectual conflict of interest." Wolfe ultimately participated as a non-voting member of the committee.

The committee concluded by a 15-11 vote that the products had a favorable risk-benefit ratio, and 21-5 in favor of labeling changes to indicate a higher likelihood of blood clots as a result of taking the products.